1. Field of the Invention
This invention relates to a surgical device, and more particularly to an anastomosis ring insertion device for use in anastomosing tubular body members.
The insertion device of the subject invention inserts the anastomosis ring into the human body using a non-invasive surgical procedure. Such a procedure entails inserting the anastomosis ring through a natural body orifice. The non-invasive procedure has several advantages over invasive surgery, which inserts the anastomosis ring through a bodily incision proximate to the severed ends of the body organ, such as quicker healing time, less patient trauma and reduced risk of infection for the patient.
The subject invention can be used, for example, to anastomose the esophagus by inserting the anastomosis ring through the mouth. As another example, the insertion device of the subject invention can insert the anastomosis ring through the anal orifice of the patient to anastomose the lower colon, or bowel section, of the intestines.
After a surgical procedure such as cutting and removing a diseased or cancerous portion of a tubular body member, the severed ends of the body organ must be anastomosed. Several procedures are available for connecting together two sections of hollow tubular body members such as the intestines. Known procedures include suturing, stapling or clamping the severed ends together. For example, U.S. Pat. Nos. 4,576,167; 4,603,693 and 4,646,745 are directed to circular surgical staplers for joining hollow body organs.
Another procedure using anastomosis buttons and clamps is disclosed in U.S. Pat. Nos. 3,771,526, 4,055,186 and 4,154,241. These devices may utilize inserter rods which are forced upwardly into the rectum through the anus to position one half of a clamp device in the lower colon and engage the other half of the clamp device positioned in the upper colon to draw the two halves together.
Still another procedure involves use of an anastomotic device that is the subject of U.S. Pat. Nos. 4,467,804, 4,552,148 and 4,766,898, which are assigned to the assignee of the present application, and marketed and sold under the VALTRAC.RTM. trademark. The insertion device of the subject invention is used in conjunction with an anastomotic device of the type disclosed in these patents. The anastomotic device receives the open ends of two tubular body members to be anastomosed over a pair of ring members. The ring members have annular connecting means which mate with each other to clamp the body organs contiguous to each other so they can grow and heal together.
The anastomotic device, which will be referred to hereinafter and in its embodiment for use with the subject invention as an anastomosis ring, is pictured in FIGS. 7 through 9. A complete anastomoses ring 11 is shown in FIG. 7 and is comprised of two identical unitary members 13 of mushroom cap configuration. FIGS. 8 and 9 show a bottom plan view and a top plan view, respectively, of the unitary member. The bottom plan view in FIG. 8 shows a ring member 15 having a pair of diametrically opposed depending legs 17 each supporting a plurality of engaging pawls 19. Alternately positioned between the depending legs and opposite to each other are depending engaging members 21, each of which has a pawl engaging recess 23 to cooperatively receive the pawls when the two unitary members 13 are joined together to form the anastomosis ring. For ease of reference, the ring member will be referred to as the head of the anastomosis ring and the depending legs and engaging members will be referred to as the neck.
FIG. 9 shows the top of the unitary member molded to form four notches 25 and four ridges 27 alternately positioned around its inner periphery.
As shown in FIG. 7, the pawls 19 are positioned on each depending leg 17 such that the unitary members can mate in an engaged position as shown in solid lines, or in a fully closed position as shown in solid and broken lines. As will be discussed in greater detail below, the unitary members are mounted on the insertion device of the subject invention in the engaged position and then inserted into the body. A profile of the engaging pawl showing engaging edge 29 and slope 31 can also be seen in FIG. 7.
The unitary members 13 are formed of a bio-absorbable bio-fragmentable material that permits disintegration of the device in a relatively short period of time after healing of the tubular body member ends begins. Acceptable materials for forming the anastomosis rings are disclosed in U.S. Pat. No. 3,297,033 and are referred to as poly-hydroxyacetic ester and lactide copolymers. Molded surgical articles made from a wide variety of glycolide/lactide copolymers are well known in the art.
2. Description of the Prior Art
U.S. Pat. No. 4,667,673, also assigned to the assignee of the present application, discloses an applicator device for mounting and inserting the anastomosis ring in a bowel section of the patient and a method for using the applicator. The device includes a mounting extension for mounting the two halves of the anastomosis ring and an inserter which may be curved. The two halves are spaced apart from each other in the mounted position and then drawn together by manipulation of the inserter. The inserter portion of the applicator passes through the interior of the rectum and out through the exterior of the anus so that the placement of the anastomosis ring can be done without being exposed to the dirty and contaminated end of the bowel.
European Patent Publication No. 540,010, published May 5, 1993, discloses a clamping device for approximating and joining two ends of tubular tissue. First and second clamping members are purse-string sutured to opposing open ends of a tubular body member. The first clamping member includes a ratchet-surfaced central shaft and an actuating shaft. A cable is attached to the second clamping member and extends through the actuating shaft to be pulled by a surgeon/user to draw the second clamping member toward the ratchet-surfaced central shaft of the first clamping member to close the gap between the clamping members and compress together the open ends of the tubular body member. The cable is cut by a blade on the actuating shaft, which is then withdrawn axially from the body. The publication discloses use of the VALTRAC.RTM. anastomosis ring as an alternative to the first and second clamping members.